PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2035 

Public Law 113–195 

113th Congress 

An Act 

To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative 

process for review of safety and effectiveness of nonprescription sunscreen active 

ingredients and for other purposes. 

Be it enacted by the Senate and House of Representatives of 

the United States of America in Congress assembled, 

SECTION 1. SHORT TITLE. 

This Act may be cited as the ‘‘Sunscreen Innovation Act’’. 

SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN ACTIVE 

INGREDIENTS. 

(a) IN GENERAL.—Chapter V of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 

the end the following: 

‘‘Subchapter I—Nonprescription Sunscreen and Other 

Active Ingredients 

‘‘SEC. 586. DEFINITIONS. 

‘‘In this subchapter— 

‘‘(1) the term ‘Advisory Committee’ means the Nonprescription Drug Advisory Committee of the Food and Drug Administration or any successor to such Committee; 

‘‘(2) the term ‘final sunscreen order’ means an order published by the Secretary in the Federal Register containing 

information stating that a nonprescription sunscreen active 

ingredient or combination of nonprescription sunscreen active 

ingredients— 

‘‘(A) is GRASE and is not misbranded if marketed 

in accordance with such order; or 

‘‘(B) is not GRASE and is misbranded; 

‘‘(3) the term ‘GRASE’ means generally recognized, among 

experts qualified by scientific training and experience to 

evaluate the safety and effectiveness of drugs, as safe and 

effective for use under the conditions prescribed, recommended, 

or suggested in the labeling of a drug as described in section 

201(p); 

‘‘(4) the term ‘GRASE determination’ means, with respect 

to a nonprescription active ingredient or a combination of nonprescription active ingredients, a determination of whether such 

ingredient or combination of ingredients is GRASE; 

‘‘(5) the term ‘nonprescription’ means not subject to section 

503(b)(1); 

21 USC 360fff. 

21 USC 301 note. 

Sunscreen 

Innovation Act. 

Nov. 26, 2014 

[S. 2141] 


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128 STAT. 2036 PUBLIC LAW 113–195—NOV. 26, 2014 

‘‘(6) the term ‘pending request’ means each request with 

respect to a nonprescription sunscreen active ingredient submitted under section 330.14 of title 21, Code of Federal Regulations (as in effect on the date of enactment of the Sunscreen 

Innovation Act) for consideration for inclusion in the overthe-counter drug monograph system— 

‘‘(A) that was determined to be eligible for such review 

by publication of a notice of eligibility in the Federal Register prior to the date of enactment of such Act; and 

‘‘(B) for which safety and effectiveness data have been 

submitted to the Secretary prior to such date of enactment; 

‘‘(7) the term ‘proposed sunscreen order’ means an order 

containing a tentative determination published by the Secretary 

in the Federal Register containing information proposing that 

a nonprescription sunscreen active ingredient or combination 

of nonprescription sunscreen active ingredients— 

‘‘(A) is GRASE and is not misbranded if marketed 

in accordance with such order; 

‘‘(B) is not GRASE and is misbranded; or 

‘‘(C) is not GRASE and is misbranded because the 

data are insufficient to classify such ingredient or combination of ingredients as GRASE and not misbranded and 

additional information is necessary to allow the Secretary 

to determine otherwise; 

‘‘(8) the term ‘sponsor’ means the person that submitted— 

‘‘(A) a request under section 586A; 

‘‘(B) a pending request; or 

‘‘(C) any other application subject to this subchapter; 

‘‘(9) the term ‘sunscreen’ means a drug containing one 

or more sunscreen active ingredients; and 

‘‘(10) the term ‘sunscreen active ingredient’ means an active 

ingredient that is intended for application to the skin of humans 

for purposes of absorbing, reflecting, or scattering ultraviolet 

radiation. 

‘‘SEC. 586A. SUBMISSION OF REQUESTS. 

‘‘Any person may submit a request to the Secretary for a 

determination of whether a nonprescription sunscreen active ingredient or a combination of nonprescription sunscreen active ingredients, for use under specified conditions, to be prescribed, recommended, or suggested in the labeling thereof (including dosage 

form, dosage strength, and route of administration) is GRASE and 

should be included in part 352 of title 21, Code of Federal Regulations (or any successor regulations) concerning nonprescription sunscreen. 

‘‘SEC. 586B. ELIGIBILITY DETERMINATIONS; DATA SUBMISSION; 

FILING. 

‘‘(a) ELIGIBILITY DETERMINATIONS.— 

‘‘(1) IN GENERAL.—Not later than 60 calendar days after 

the date of receipt of a request under section 586A, the Secretary shall— 

‘‘(A) determine, in accordance with paragraph (2), 

whether the request is eligible for further review under 

subsection (b) and section 586C; 

‘‘(B) notify the sponsor of the determination of the 

Secretary; and 

Notification. 

Deadline. 

21 USC 360fff–2. 

21 USC 360fff–1. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2037 

‘‘(C) make such determination publicly available in 

accordance with paragraph (3) and subsection (b)(1). 

‘‘(2) CRITERIA FOR ELIGIBILITY.— 

‘‘(A) IN GENERAL.—To be eligible for review under subsection (b) and section 586C, a request shall be for a 

nonprescription sunscreen active ingredient or combination 

of nonprescription sunscreen active ingredients, for use 

under specified conditions, to be prescribed, recommended, 

or suggested in the labeling thereof, that— 

‘‘(i) is not included in part 352 of title 21, Code 

of Federal Regulations (or any successor regulations) 

concerning nonprescription sunscreen; and 

‘‘(ii) has been used to a material extent and for 

a material time under such conditions, as described 

in section 201(p)(2). 

‘‘(B) ESTABLISHMENT OF TIME AND EXTENT.—A sponsor 

shall include in a request under section 586A the information required under section 330.14 of title 21, Code of 

Federal Regulations (or any successor regulations) to meet 

the standard described in subparagraph (A)(ii). 

‘‘(3) PUBLIC AVAILABILITY.— 

‘‘(A) REDACTIONS FOR CONFIDENTIAL INFORMATION.— 

If a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients 

is determined under paragraph (1)(A) to be eligible for 

further review, the Secretary shall make the request publicly available, with redactions for information that is 

treated as confidential under section 552(b) of title 5, 

United States Code, section 1905 of title 18, United States 

Code, or section 301(j) of this Act. 

‘‘(B) IDENTIFICATION OF CONFIDENTIAL INFORMATION BY

SPONSOR.—At the time that a request is made under section 

586A, the sponsor of such request shall identify any 

information that such sponsor considers to be confidential 

information described in subparagraph (A). 

‘‘(C) CONFIDENTIALITY DURING ELIGIBILITY REVIEW.— 

The information contained in a request under section 586A 

shall remain confidential during the Secretary’s consideration under this section of whether the request is eligible 

for further review consistent with section 330.14 of title 

21, Code of Federal Regulations (or any successor regulations). 

‘‘(b) DATA SUBMISSION AND FILING OF REQUESTS.— 

‘‘(1) IN GENERAL.—In the case of a request under section 

586A that is determined to be eligible under subsection (a) 

for further review under this section and section 586C, the 

Secretary shall, in notifying the public under subsection 

(a)(1)(C) of such eligibility determination, post the eligibility 

determination on the Internet website of the Food and Drug 

Administration, invite the sponsor of such request and any 

other interested party to submit comments, and provide a 

period of not less than 45 calendar days for comments in 

support of or otherwise relating to a GRASE determination, 

including published and unpublished data and other information related to the safety and efficacy of such request. 

‘‘(2) FILING DETERMINATION.—Not later than 60 calendar 

days after the submission of data and other information 

Deadlines. 

Web posting. 

Deadline. 

Public 

information. 


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128 STAT. 2038 PUBLIC LAW 113–195—NOV. 26, 2014 

described in paragraph (1) by the sponsor, the Secretary shall 

determine whether the data and other information submitted 

by the sponsor under this section are sufficiently complete, 

including being formatted in a manner that enables the Secretary to determine the completeness of such data and information, to enable the Secretary to conduct a substantive review 

under section 586C with respect to such request. Not later 

than 60 calendar days after the submission of data and other 

information described in paragraph (1) by the sponsor, if the 

Secretary determines— 

‘‘(A) that such data and other information are sufficiently complete, the Secretary shall— 

‘‘(i) issue a written notification to the sponsor of 

the determination to file such request, and make such 

notification publicly available; and 

‘‘(ii) file such request made under section 586A; 

or 

‘‘(B) that such data and other information are not 

sufficiently complete, the Secretary shall issue a written 

notification to the sponsor of the determination to refuse 

to file the request, which shall include the reasons for 

the refusal, including why such data and other information 

are not sufficiently complete, and make such notification 

publicly available. 

‘‘(3) REFUSAL TO FILE A REQUEST.— 

‘‘(A) REQUEST FOR MEETINGS; SUBMISSION OF ADDITIONAL DATA OR OTHER INFORMATION.—If the Secretary 

refuses to file a request made under section 586A, the 

sponsor may— 

‘‘(i) within 30 calendar days of receipt of written 

notification of such refusal, request, in writing, a 

meeting with the Secretary regarding the filing determination; and 

‘‘(ii) submit additional data or other information. 

‘‘(B) MEETINGS.— ‘‘(i) IN GENERAL.—If a sponsor seeks a meeting 

under subparagraph (A)(i), the Secretary shall convene 

the meeting within 30 calendar days of the request 

for such meeting. 

‘‘(ii) ACTIONS AFTER MEETING.—Following any 

meeting held under clause (i)— 

‘‘(I) the Secretary may file the request within 

60 calendar days; 

‘‘(II) the sponsor may submit additional data 

or other information; or 

‘‘(III) if the sponsor elects, within 120 calendar 

days, to have the Secretary file the request (with 

or without amendments to correct any purported 

deficiencies to the request)— 

‘‘(aa) the Secretary shall file the request 

over protest, not later than 30 calendar days 

after the sponsor makes such election; 

‘‘(bb) at the time of filing, the Secretary 

shall provide written notification of such filing 

to the sponsor; and 

‘‘(cc) the Secretary shall make such 

notification publicly available. 

Public 

information. 

Notification. 

Notification. 

Deadlines. 

Notification. 

Public 

information. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2039 

‘‘(iii) REQUESTS FILED OVER PROTEST.—The Secretary shall not require the sponsor to resubmit a 

copy of the request for purposes of filing a request 

filed over protest, as described in clause (ii)(III). 

‘‘(C) SUBMISSIONS OF ADDITIONAL DATA OR OTHER

INFORMATION.—Within 60 calendar days of any submission 

of additional data or other information under subparagraph 

(A)(ii) or (B)(ii)(II), the Secretary shall reconsider the previous determination made under paragraph (2) with respect 

to the applicable request and make a new determination 

in accordance with paragraph (2). 

‘‘(4) PUBLIC AVAILABILITY.— ‘‘(A) REDACTIONS FOR CONFIDENTIAL INFORMATION.— After the period of confidentiality described in subsection 

(a)(3)(C), the Secretary shall make data and other information submitted in connection with a request under section 

586A publicly available, with redactions for information 

that is treated as confidential under section 552(b) of title 

5, United States Code, section 1905 of title 18, United 

States Code, or section 301(j) of this Act. 

‘‘(B) IDENTIFICATION OF CONFIDENTIAL INFORMATION BY

SPONSOR.—A person submitting information under this section shall identify at the time of such submission the portions of such information that the person considers to be 

confidential information described in subparagraph (A). 

‘‘SEC. 586C. GRASE DETERMINATION. 

‘‘(a) REVIEW OF NEW REQUEST.— 

‘‘(1) PROPOSED SUNSCREEN ORDER.—In the case of a request 

under section 586A, not later than 300 calendar days after 

the date on which such request is filed under subsection 

(b)(2)(A) or (b)(3)(B)(ii)(III) of section 586B, the Secretary— 

‘‘(A) may convene a meeting of the Advisory Committee 

to review such request; and 

‘‘(B) shall complete the review of such request and 

issue a proposed sunscreen order with respect to such 

request. 

‘‘(2) PROPOSED SUNSCREEN ORDER BY COMMISSIONER.—If 

the Secretary does not issue a proposed sunscreen order under 

paragraph (1)(B) within such 300-day period, the sponsor of 

such request may notify the Office of the Commissioner of 

such request and request review by the Office of the Commissioner. If such sponsor so notifies the Office of the Commissioner, the Commissioner shall, not later than 60 calendar 

days after the date of notification under this paragraph, issue 

a proposed sunscreen order with respect to such request. 

‘‘(3) PUBLIC COMMENT PERIOD.—A proposed sunscreen order 

issued under paragraph (1)(B) or (2) with respect to a request 

shall provide for a period of 45 calendar days for public comment. 

‘‘(4) MEETING.—A sponsor may request, in writing, a 

meeting with respect to a proposed sunscreen order issued 

under this subsection and described in subparagraph (B) or 

(C) of section 586(7), not later than 30 calendar days after 

the Secretary issues such order. The Secretary shall convene 

a meeting with such sponsor not later than 45 calendar days 

after such request for a meeting. 

Deadlines. 

21 USC 360fff–3. 


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128 STAT. 2040 PUBLIC LAW 113–195—NOV. 26, 2014 

‘‘(5) FINAL SUNSCREEN ORDER.—With respect to a proposed 

sunscreen order under paragraph (1)(B) or (2)— 

‘‘(A) the Secretary shall issue a final sunscreen order— 

‘‘(i) in the case of a proposed sunscreen order 

described in subparagraph (A) or (B) of section 586(7), 

not later than 90 calendar days after the end of the 

public comment period under paragraph (3); or 

‘‘(ii) in the case of a proposed sunscreen order 

described in subparagraph (C) of section 586(7), not 

later than 210 calendar days after the date on which 

the sponsor submits the additional information 

requested pursuant to such proposed sunscreen order; 

or 

‘‘(B) if the Secretary does not issue such final sunscreen 

order within such 90- or 210-calendar-day period, as 

applicable, the sponsor of such request may notify the 

Office of the Commissioner of such request and request 

review by the Office of the Commissioner. 

‘‘(6) FINAL SUNSCREEN ORDER BY COMMISSIONER.—The 

Commissioner shall issue a final sunscreen order with respect 

to a proposed sunscreen order subject to paragraph (5)(B) not 

later than 60 calendar days after the date of notification under 

such paragraph. 

‘‘(b) REVIEW OF PENDING REQUESTS.— 

‘‘(1) IN GENERAL.—The review of a pending request shall 

be carried out by the Secretary in accordance with this subsection. 

‘‘(2) INAPPLICABILITY OF SECTIONS 586A AND 586B.—Sections 

586A and 586B shall not apply with respect to any pending 

request. 

‘‘(3) FEEDBACK LETTERS AS PROPOSED SUNSCREEN ORDER.— 

Notwithstanding the requirements of section 586(7), a letter 

issued pursuant to section 330.14(g) of title 21, Code of Federal 

Regulations before the date of enactment of the Sunscreen 

Innovation Act, with respect to a pending request, shall be 

deemed to be a proposed sunscreen order and displayed on 

the Internet website of the Food and Drug Administration. 

Notification of the availability of such letter shall be published 

in the Federal Register not later than 45 calendar days after 

the date of enactment of such Act. 

‘‘(4) PROPOSED SUNSCREEN ORDER.—In the case of a pending 

request for which the Secretary has not issued a letter pursuant 

to section 330.14(g) of title 21, Code of Federal Regulations 

before the date of enactment of the Sunscreen Innovation Act, 

the Secretary shall complete review of such request and, not 

later than 90 calendar days after the date of enactment of 

such Act, issue a proposed sunscreen order with respect to 

such request. 

‘‘(5) PROPOSED SUNSCREEN ORDER BY COMMISSIONER.—If 

the Secretary does not issue a proposed sunscreen order under 

paragraph (4), or the Secretary does not publish a notification 

of the availability of a letter under paragraph (3), as applicable, 

the sponsor of such request may notify the Office of the Commissioner of such request and request review by the Office of 

the Commissioner. The Commissioner shall, not later than 

60 calendar days after the date of notification under this paragraph, issue a proposed order with respect to such request. 

Notification. 

Federal Register, 

publication. 

Web posting. 

Deadlines. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2041 

‘‘(6) PUBLIC COMMENT PERIOD.—A proposed sunscreen order 

issued under paragraph (4) or (5), or a notification of the 

availability of a letter under paragraph (3), with respect to 

a pending request shall provide for a period of 45 calendar 

days for public comment. 

‘‘(7) MEETING.—A sponsor may request, in writing, a 

meeting with respect to a proposed sunscreen order issued 

under this subsection, including a letter deemed to be a proposed sunscreen order under paragraph (3), not later than 

30 calendar days after the Secretary issues such order or the 

date upon which such feedback letter is deemed to be a proposed 

sunscreen order, as applicable. The Secretary shall convene 

a meeting with such sponsor not later than 45 calendar days 

after the date of such request for a meeting. 

‘‘(8) ADVISORY COMMITTEE.—In the case of a proposed sunscreen order under paragraph (3), (4), or (5), an Advisory Committee meeting may be convened for the purpose of reviewing 

and providing recommendations regarding the pending request. 

‘‘(9) FINAL SUNSCREEN ORDER.—In the case of a proposed 

sunscreen order under paragraph (3), (4), or (5)— 

‘‘(A) the Secretary shall issue a final sunscreen order 

with respect to the request— 

‘‘(i) in the case of a proposed sunscreen order 

described in subparagraph (A) or (B) of section 586(7), 

not later than 90 calendar days after the end of the 

public comment period under paragraph (6); or 

‘‘(ii) in the case of a proposed sunscreen order 

described in subparagraph (C) of section 586(7)— 

‘‘(I) if the Advisory Committee is not convened 

under paragraph (8), not later than 210 calendar 

days after the date on which the sponsor submits 

the additional information requested pursuant to 

such proposed sunscreen order, which shall include 

a rationale for not convening such Advisory Committee; or 

‘‘(II) if the Advisory Committee is convened 

under paragraph (8), not later than 270 calendar 

days after the date on which the sponsor submits 

such additional information; or 

‘‘(B) if the Secretary does not issue such final sunscreen 

order within such 90-, 210-, or 270-calendar-day period, 

as applicable, the sponsor of such request may notify the 

Office of the Commissioner about such request and request 

review by the Office of the Commissioner. 

‘‘(10) FINAL SUNSCREEN ORDER BY COMMISSIONER.—The 

Commissioner shall issue a final sunscreen order with respect 

to a proposed sunscreen order subject to paragraph (9)(B) not 

later than 60 calendar days after the date of notification under 

such paragraph. 

‘‘(c) ADVISORY COMMITTEE.—The Secretary shall not be required 

to— 

‘‘(1) convene the Advisory Committee— 

‘‘(A) more than once with respect to any request under 

section 586A or any pending request; or 

‘‘(B) more than twice in any calendar year with respect 

to the review under this section; or 

Notification. 


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128 STAT. 2042 PUBLIC LAW 113–195—NOV. 26, 2014 

‘‘(2) submit more than a total of 3 requests under section 

586A or pending requests to the Advisory Committee per 

meeting. 

‘‘(d) NO DELEGATION.—Any responsibility vested in the Commissioner by subsection (a)(2), (a)(6), (b)(5), or (b)(10) shall not be 

delegated. 

‘‘(e) EFFECT OF FINAL SUNSCREEN ORDER.— ‘‘(1) IN GENERAL.— ‘‘(A) SUNSCREEN ACTIVE INGREDIENTS DETERMINED TO

BE GRASE.—Upon issuance of a final sunscreen order determining that a nonprescription sunscreen active ingredient 

or combination of nonprescription sunscreen active ingredients is GRASE and is not misbranded, a sunscreen containing such ingredient or combination of ingredients shall 

be permitted to be introduced or delivered into interstate 

commerce for use under the conditions described in such 

final sunscreen order, in accordance with all requirements 

applicable to drugs not subject to section 503(b)(1), for 

so long as such final sunscreen order remains in effect. 

‘‘(B) SUNSCREEN ACTIVE INGREDIENTS DETERMINED NOT

TO BE GRASE.—Upon issuance of a final sunscreen order 

determining that a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active 

ingredients is not GRASE and is misbranded, a sunscreen 

containing such ingredient or combination of ingredients 

shall not be introduced or delivered into interstate commerce, for use under the conditions described in such final 

sunscreen order, unless an application is approved pursuant to section 505 with respect to a sunscreen containing 

such ingredient or combination of ingredients, or unless 

conditions are later established under which such ingredient or combination of ingredients is later determined 

to be GRASE and not misbranded under the over-thecounter drug monograph system. 

‘‘(2) AMENDMENTS TO FINAL SUNSCREEN ORDERS.— ‘‘(A) AMENDMENTS AT INITIATIVE OF SECRETARY.—In 

the event that information relevant to a nonprescription 

sunscreen active ingredient or combination of nonprescription sunscreen active ingredients becomes available to the 

Secretary after issuance of a final sunscreen order, the 

Secretary may amend such final sunscreen order by issuing 

a new proposed sunscreen order under subsection (a)(1) 

and following the procedures set forth in this section. 

‘‘(B) PETITION TO AMEND FINAL ORDER.—Any interested 

person may petition the Secretary to amend a final sunscreen order under section 10.30, title 21 Code of Federal 

Regulations (or any successor regulations). If the Secretary 

grants any petition under such section, the Secretary shall 

initiate the process for amending a final sunscreen order 

by issuing a new proposed sunscreen order under subsection (a)(1) and following the procedures set forth in 

this section. 

‘‘(C) APPLICABILITY OF FINAL ORDERS.—Once the Secretary issues a new proposed sunscreen order to amend 

a final sunscreen order under subparagraph (A) or (B), 

such final sunscreen order shall remain in effect and paragraph (3) shall not apply to such final sunscreen order 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2043 

until the Secretary has issued a new final sunscreen order 

or has determined not to amend the final sunscreen order. 

‘‘(3) INCLUSION OF INGREDIENTS THAT ARE SUBJECTS OF

FINAL ORDERS IN THE SUNSCREEN MONOGRAPH.— 

‘‘(A) AMENDING REGULATIONS.— 

‘‘(i) REQUIREMENT.—At any time that the Secretary 

proposes to amend part 352 of title 21, Code of Federal 

Regulations (or any successor regulations) concerning 

nonprescription sunscreen, including pursuant to section 586E, except as provided in clause (iv), the Secretary shall include in such part 352 (or any successor 

regulations) any nonprescription sunscreen active 

ingredient or combination of nonprescription sunscreen 

active ingredients that is the subject of an effective 

final sunscreen order of the type described in section 

586(2)(A) and issued since the time that the Secretary 

last amended such regulations. Such regulation shall 

set forth conditions of use under which each such ingredient or combination of ingredients is GRASE and 

not misbranded. If these conditions differ from, or are 

in addition to, those previously set forth in the 

applicable final sunscreen order, the Secretary shall 

provide notice and opportunity for comment on such 

conditions in the rulemaking, and the applicable final 

sunscreen order shall continue in effect until the effective date of a final regulation, as set forth in clause 

(iii). 

‘‘(ii) INCLUSION OF ORDERS.—In proposing to amend 

the regulations as described in clause (i), the Secretary 

shall include in the proposed regulations a list of final 

sunscreen orders that shall cease to be effective on 

the effective date of a resulting final regulation. Such 

list shall include all final sunscreen orders of the type 

described in section 586(2)(A) that are in effect on 

the date that such regulations are proposed, with the 

exception that such list shall not include any final 

sunscreen orders that, on the date that the regulations 

are proposed, the Secretary is in the process of 

amending under paragraph (2). 

‘‘(iii) ORDERS NO LONGER EFFECTIVE.—Any final 

sunscreen order included by the Secretary in a list 

described in clause (ii) and in a list included in 

resulting final regulations shall cease to be effective 

on the date that such final regulations including such 

order in such list become effective. 

‘‘(iv) INGREDIENTS NOT GRASE.—If, notwithstanding 

a final sunscreen order stating that a nonprescription 

sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE 

and is not misbranded if marketed in accordance with 

such order, while amending the regulations as 

described in clause (i), the Secretary concludes that 

such ingredient or combination of ingredients is no 

longer GRASE for use in nonprescription sunscreen, 

the Secretary shall, at the discretion of the Secretary, 

Lists. 

Termination 

date. 

Notification. 

Public comments. 

Extension. 


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128 STAT. 2044 PUBLIC LAW 113–195—NOV. 26, 2014 

either initiate the process for amending the final sunscreen order set forth in paragraph (2) of this subsection or include in a proposed regulation an explanation and information supporting the determination 

of the Secretary that such ingredient or combination 

of ingredients is no longer GRASE for use in nonprescription sunscreen. 

‘‘(B) PROCEDURE FOR UPDATING REGULATIONS.—After 

the Secretary amends and finalizes the regulations under 

part 352 of title 21, Code of Federal Regulations under 

section 586E and such regulations become effective, the 

Secretary may use direct final rulemaking to include in 

such regulations any nonprescription sunscreen active 

ingredients that are the subject of effective final sunscreen 

orders. 

‘‘SEC. 586D. GUIDANCE; OTHER PROVISIONS. 

‘‘(a) GUIDANCE.— 

‘‘(1) IN GENERAL.— 

‘‘(A) DRAFT GUIDANCE.—Not later than 1 year after 

the date of enactment of the Sunscreen Innovation Act, 

the Secretary shall issue draft guidance on the implementation of, and compliance with, the requirements with respect 

to sunscreen under this subchapter, including guidance 

on— 

‘‘(i) the format and content of information submitted by a sponsor in support of a request under 

section 586A or a pending request; 

‘‘(ii) the data required to meet the safety and efficacy standard for determining whether a nonprescription sunscreen active ingredient or combination of nonprescription sunscreen active ingredients is GRASE 

and is not misbranded; 

‘‘(iii) the process by which a request under section 

586A or a pending request is withdrawn; and 

‘‘(iv) the process by which the Secretary will carry 

out section 586C(c), including with respect to how the 

Secretary will address the total number of requests 

received under section 586A and pending requests. 

‘‘(B) FINAL GUIDANCE.—The Secretary shall finalize the 

guidance described in subparagraph (A) not later than 

2 years after the date of enactment of the Sunscreen 

Innovation Act. 

‘‘(C) INAPPLICABILITY OF PAPERWORK REDUCTION ACT.— 

Chapter 35 of title 44, United States Code shall not apply 

to collections of information made for purposes of guidance 

under this subsection. 

‘‘(2) SUBMISSIONS PENDING ISSUANCE OF FINAL GUIDANCE.— 

Irrespective of whether final guidance under paragraph (1) 

has been issued— 

‘‘(A) persons may, beginning on the date of enactment 

of the Sunscreen Innovation Act, make submissions under 

this subchapter; and 

‘‘(B) the Secretary shall review and act upon such 

submissions in accordance with this subchapter. 

‘‘(b) RULES OF CONSTRUCTION.— 

Review. 

Deadline. 

Deadline. 

21 USC 360fff–4. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2045 

‘‘(1) CURRENTLY MARKETED SUNSCREENS.—Nothing in this 

subchapter shall be construed to affect the marketing of sunscreens that are marketed in interstate commerce on or before 

the date of enactment of this subchapter, except as otherwise 

provided in this subchapter. 

‘‘(2) ENSURING SAFETY AND EFFECTIVENESS.—Nothing in 

this subchapter shall be construed to alter the authority of 

the Secretary with respect to prohibiting the marketing of 

a sunscreen that is not safe and effective or is misbranded, 

or with respect to imposing restrictions on the marketing of 

a sunscreen to ensure safety and effectiveness, except as otherwise provided in this subchapter, including section 586C(e). 

‘‘(3) OTHER DRUGS.—Except as otherwise provided in section 

586F, nothing in this subchapter shall be construed to affect 

the authority of the Secretary under this Act or the Public 

Health Service Act (42 U.S.C. 201 et seq.) with respect to 

a drug other than a nonprescription sunscreen. 

‘‘(4) EFFECT ON DRUGS OTHERWISE APPROVED.—Nothing in 

this subchapter shall affect the marketing of a drug approved 

under section 505 of this Act or section 351 of the Public 

Health Service Act. 

‘‘(c) TIMELINES.—The timelines for the processes and procedures 

under paragraphs (1), (2), (5), and (6) of section 586C(a) shall 

not apply to any requests submitted to the Secretary under section 

586A after the date that is 6 years after the date of enactment 

of the Sunscreen Innovation Act. 

‘‘SEC. 586E. SUNSCREEN MONOGRAPH. 

‘‘(a) IN GENERAL.—Not later than 5 years after the date of 

enactment of the Sunscreen Innovation Act, the Secretary shall 

amend and finalize regulations under part 352 of title 21, Code 

of Federal Regulations concerning nonprescription sunscreen that 

are effective not later than 5 years after such date of enactment. 

The Secretary shall publish such regulations not less than 30 calendar days before the effective date of such regulations. 

‘‘(b) REPORTS.—If the regulations promulgated under subsection 

(a) do not include provisions related to the effectiveness of various 

sun protection factor levels, and do not address all dosage forms 

known to the Secretary to be used in sunscreens marketed in 

the United States without a new drug approval under section 505, 

the Secretary shall submit a report to the Committee on Health, 

Education, Labor, and Pensions of the Senate and the Committee 

on Energy and Commerce of the House of Representatives on the 

rationale for such provisions not being included in such regulations, 

and a plan and timeline to compile any information necessary 

to address such provisions through final regulations.’’. 

(b) RULES OF CONSTRUCTION.—Nothing in the amendment made 

by this section shall be construed to— 

(1) limit the right of a sponsor (as defined in section 586(8) 

of the Federal Food, Drug, and Cosmetic Act, as added by 

subsection (a)) to request that the Secretary of Health and 

Human Services convene an advisory committee; or 

(2) limit the authority of the Secretary of Health and 

Human Services to meet with a sponsor (as defined in section 

586(8) of the Federal Food, Drug, and Cosmetic Act, as added 

by subsection (a)). 

21 USC 360 note. 

Publication. 

Deadlines. 

Regulations. 

21 USC 360fff–5. 


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128 STAT. 2046 PUBLIC LAW 113–195—NOV. 26, 2014 

SEC. 3. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS. 

Subchapter I of chapter V of the Federal Food, Drug, and 

Cosmetic Act, as added by section 2, is amended by adding at 

the end the following: 

‘‘SEC. 586F. NON-SUNSCREEN TIME AND EXTENT APPLICATIONS. 

‘‘(a) PENDING TIME AND EXTENT APPLICATIONS.— ‘‘(1) IN GENERAL.— ‘‘(A) REQUEST FOR FRAMEWORK FOR REVIEW.—If, prior 

to the date of enactment of the Sunscreen Innovation Act, 

an application was submitted pursuant to section 330.14 

of title 21, Code of Federal Regulations for a GRASE determination for a drug other than a nonprescription sunscreen 

active ingredient or combination of nonprescription sunscreen active ingredients and such drug was found to be 

eligible to be considered for inclusion in the over-thecounter drug monograph system pursuant to section 330.14 

of title 21, Code of Federal Regulations, the sponsor of 

such application may request that the Secretary provide 

a framework under paragraph (2) for the review of such 

application. 

‘‘(B) REQUEST REQUIREMENTS.—A request for a framework for review of an application made under subparagraph 

(A) shall be made within 180 calendar days of the date 

of enactment of the Sunscreen Innovation Act and shall 

include the preference of such sponsor as to whether such 

application is reviewed by the Secretary in accordance 

with— 

‘‘(i) the processes and procedures set forth for 

pending requests under section 586C(b), except that 

specific timelines shall be determined in accordance 

with other applicable requirements under this section; 

‘‘(ii) the processes and procedures set forth under 

part 330 of title 21, Code of Federal Regulations (or 

any successor regulations); 

‘‘(iii) an initial filing determination under the processes and procedures described in section 586B(b) and 

the processes and procedures set forth for pending 

requests under section 586C(b), except that specific 

timelines shall be determined in accordance with other 

applicable requirements under this section; or 

‘‘(iv) an initial filing determination under the processes and procedures described in section 586B(b) and 

the processes and procedures set forth under part 330 

of title 21, Code of Federal Regulations (or any successor regulations). 

‘‘(C) NO REQUEST.—If a sponsor described in subparagraph (A) does not make such request within 180 calendar 

days of the date of enactment of the Sunscreen Innovation 

Act, such application shall be reviewed by the Secretary 

in accordance with the timelines of the applicable regulations when such regulations are finalized under subsection 

(b). 

‘‘(2) FRAMEWORK.—Not later than 1 year after the date 

of enactment of the Sunscreen Innovation Act, the Secretary 

shall provide, in writing, a framework to each sponsor that 

submitted a request under paragraph (1). Such framework shall 

Deadline. 

Notification. 

Deadlines. 

21 USC 360fff–6. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2047 

set forth the various timelines, in calendar days, with respect 

to the processes and procedures for review under clauses (i), 

(ii), (iii), and (iv) of paragraph (1)(B) and— 

‘‘(A) such timelines shall account for the considerations 

under paragraph (5); and 

‘‘(B) the timelines for the various processes and procedures shall not be shorter than the timelines set forth 

for pending requests under sections 586B(b) and 586C(b), 

as applicable. 

‘‘(3) GOVERNING PROCESSES AND PROCEDURES FOR REVIEW.— ‘‘(A) ELECTION.—Not later than 60 calendar days after 

the Secretary provides a framework to a sponsor under 

paragraph (2), such sponsor may provide an election to 

the Secretary regarding the processes and procedures for 

review under clause (i), (ii), (iii), or (iv) of paragraph (1)(B). 

If such sponsor makes such election, the Secretary shall 

review the application that is the subject of such election 

pursuant to the processes and procedures elected by such 

sponsor and the applicable timelines in calendar days set 

forth under such framework, which the Secretary shall 

confirm in writing to the sponsor not later than the date 

upon which the Secretary provides a report under paragraph (4). If such sponsor does not make such election, 

such application shall be reviewed by the Secretary in 

accordance with the timelines of the applicable regulations 

when such regulations are finalized under subsection (b). 

‘‘(B) DIFFERENT PROCESSES AND PROCEDURES.—At any 

time during review of an application, the Secretary may 

review such application under different processes and 

procedures under clause (i), (ii), (iii), or (iv) of paragraph 

(1)(B) than the processes and procedures the sponsor 

elected in accordance with subparagraph (A), so long as 

the Secretary proposes, in writing, the change and the 

sponsor agrees, in writing, to such change. 

‘‘(C) INCLUSION OF INGREDIENTS IN MONOGRAPHS.—If 

the sponsor elects to use the processes and procedures 

for review in accordance with clause (i) or (iii) of paragraph 

(1)(B), the Secretary may incorporate any resulting final 

order into a regulation addressing the conditions under 

which other drugs in the same therapeutic category are 

GRASE and not misbranded, including through direct final 

rulemaking, and the final order so incorporated shall cease 

to be effective on the effective date of the final regulation 

that addresses such drug. 

‘‘(4) LETTER REGARDING PENDING APPLICATIONS.—Not later 

than 18 months after the date of enactment of the Sunscreen 

Innovation Act, the Secretary shall report to the Committee 

on Health, Education, Labor, and Pensions of the Senate and 

the Committee on Energy and Commerce of the House of Representatives, in writing, regarding all pending applications subject to paragraph (1). In such letter, the Secretary shall provide 

a report on the review of such applications, including the 

timelines, in calendar days, for the review and GRASE determination for each application. Such timelines shall account 

for the considerations under paragraph (5). 

‘‘(5) TIMELINES.—The timelines in calendar days established by the Secretary pursuant to this subsection— 


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128 STAT. 2048 PUBLIC LAW 113–195—NOV. 26, 2014 

‘‘(A) may vary based on the content, complexity, and 

format of the application submitted to the Secretary; and 

‘‘(B) shall— 

‘‘(i) reflect the public health priorities of the Food 

and Drug Administration, including the potential 

public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph 

system; 

‘‘(ii) take into consideration the resources available 

to the Secretary for carrying out such priorities and 

the processes and procedures described in paragraphs 

(1)(B) and (2); and 

‘‘(iii) be reasonable, taking into consideration the 

requirements described in clauses (i) and (ii). 

‘‘(b) NEW TIME AND EXTENT APPLICATIONS.— ‘‘(1) IN GENERAL.—Not later than 18 months after the date 

of enactment of the Sunscreen Innovation Act, the Secretary 

shall issue proposed regulations establishing timelines for the 

review of applications for GRASE determinations for drugs 

other than nonprescription sunscreen active ingredients or combinations of nonprescription sunscreen active ingredients that 

are submitted to the Secretary after the date of enactment 

of the Sunscreen Innovation Act, under section 330.14 of title 

21, Code of Federal Regulations (or any successor regulations), 

and that are found to be eligible to be considered for inclusion 

in the over-the-counter drug monograph system pursuant to 

section 330.14 of title 21, Code of Federal Regulations (or 

any successor regulations), or that are subject to this subsection 

pursuant to paragraph (1) or (3) of subsection (a), as applicable, 

providing— 

‘‘(A) timely and efficient completion of evaluations of 

applications under section 330.14 of title 21, Code of Federal Regulations (or any successor regulations) for drugs 

other than sunscreens; and 

‘‘(B) timely and efficient completion of the review of 

the safety and effectiveness submissions pursuant to such 

applications, including establishing— 

‘‘(i) reasonable timelines, in calendar days, for the 

applicable proposed and final regulations for applications of various content, complexity, and format, and 

timelines for internal procedures related to such processes; and 

‘‘(ii) measurable metrics for tracking the extent 

to which the timelines set forth in the regulations 

are met. 

‘‘(2) TIMELINES.—The timelines in calendar days established in the regulations under paragraph (1)— 

‘‘(A) may vary based on the content, complexity, and 

format of the application submitted to the Secretary; and 

‘‘(B) shall— 

‘‘(i) reflect the public health priorities of the Food 

and Drug Administration, including the potential 

public health benefits posed by the inclusion of additional drugs in the over-the-counter drug monograph 

system; 

‘‘(ii) take into consideration the resources available 

to the Secretary for carrying out such priorities and 

Deadline. 

Regulations. 

Drugs and drug 

abuse. 


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PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2049 

the processes and procedures described in paragraph 

(1); and 

‘‘(iii) be reasonable, taking into consideration the 

requirements described in clauses (i) and (ii). 

‘‘(3) PROCEDURE.—In promulgating regulations under this 

subsection, the Secretary shall issue a notice of proposed rulemaking that includes a copy of the proposed regulation, provide 

a period of not less than 60 calendar days for comments on 

the proposed regulation, and publish the final regulation not 

less than 30 calendar days before the effective date of the 

regulation. 

‘‘(4) RESTRICTIONS.—Notwithstanding any other provision 

of law, the Secretary shall promulgate regulations implementing this section only as described in paragraphs (1), (2), 

and (3). 

‘‘(5) FINAL REGULATIONS.—The Secretary shall finalize the 

regulations under this section not later than 27 months after 

the date of enactment of the Sunscreen Innovation Act.’’. 

SEC. 4. REPORTS. 

(a) INITIAL GAO REPORT.—Not later than 3 years after the 

date of enactment of this Act, the Comptroller General of the 

United States shall submit to the Committee on Health, Education, 

Labor, and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives a report reviewing 

the overall progress of the Secretary of Health and Human Services 

in carrying out subchapter I of chapter V of the Federal Food, 

Drug, and Cosmetic Act (as added by section 2 and amended by 

section 3 and subsection (c)), including findings on and recommendations with respect to— 

(1) the progress made in completing the review of requests 

under subchapter I of chapter V of the Federal Food, Drug, 

and Cosmetic Act, including pending requests, and the feasibility of the timelines associated with such subchapter; 

(2) the role of the Office of the Commissioner of Food 

and Drugs in issuing determinations with respect to requests 

reviewed under such subchapter, including the number of 

requests transferred to the Office of the Commissioner under 

section 586C of such Act; 

(3) the extent to which advisory committees were convened 

by the Secretary regarding requests under subchapter I of 

chapter V of the Federal Food, Drug, and Cosmetic Act, 

including pending requests; and 

(4) the types of metrics that have been, or should be, 

established for the review of time and extent applications. 

(b) SUBSEQUENT GAO REPORT.—Not later than 51⁄2 years after 

the date of enactment of this Act, the Comptroller General of 

the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on 

Energy and Commerce of the House of Representatives a report 

reviewing the overall progress of the Secretary of Health and 

Human Services in carrying out subchapter I of chapter V of the 

Federal Food, Drug, and Cosmetic Act (as added by section 2 

and amended by section 3 and subsection (c)) and the regulation 

of over-the-counter drug products, including findings on and recommendations with respect to— 

Deadline. 

Regulations. 

Notice. 

Records. 

Time periods. 


srobinson on DSKB307YQ1PROD with PUBLIC LAWS
128 STAT. 2050 PUBLIC LAW 113–195—NOV. 26, 2014 

(1) updates on the matters reported on by the Comptroller 

General under subsection (a); 

(2) significant factors impacting the ability of the Food 

and Drug Administration to fulfill the mission of the agency 

with regard to the regulation of over-the-counter drug products, 

including finalizing outstanding monographs and responding 

to emerging and novel safety issues; 

(3) the performance of the Secretary in carrying out section 

586E of the Federal Food, Drug, and Cosmetic Act; 

(4) the types of metrics that have been, or should be, 

established for the review and regulation of over-the-counter 

drug products; and 

(5) timeliness, efficiency, and accountability in reviewing 

time and extent applications and safety and effectiveness 

reviews for over-the-counter drug products. 

(c) FDA REPORT.—Subchapter I of chapter V of the Federal 

Food, Drug, and Cosmetic Act, as amended by section 3, is further 

amended by adding at the end the following: 

‘‘SEC. 586G. REPORT. 

‘‘(a) IN GENERAL.— 

‘‘(1) IN GENERAL.—Not later than 18 months after the date 

of enactment of the Sunscreen Innovation Act, and on the 

dates that are 2 and 4 years thereafter, the Secretary shall 

issue a report to the Committee on Health, Education, Labor, 

and Pensions of the Senate and the Committee on Energy 

and Commerce of the House of Representatives describing 

actions taken under this subchapter. 

‘‘(2) CONTENTS.—The reports under this subsection shall 

include— 

‘‘(A) a review of the progress made in issuing GRASE 

determinations for pending requests, including the number 

of pending requests— 

‘‘(i) reviewed and the decision times for each 

request, measured from the date of the original request 

for an eligibility determination submitted by the 

sponsor; 

‘‘(ii) resulting in a determination that the nonprescription sunscreen active ingredient or combination 

of nonprescription sunscreen active ingredients is 

GRASE and is not misbranded; 

‘‘(iii) resulting in a determination that the nonprescription sunscreen active ingredient or combination 

of nonprescription sunscreen active ingredients is not 

GRASE and is misbranded and the reasons for such 

determinations; and 

‘‘(iv) for which a determination has not been made, 

and an explanation for the delay, a description of the 

current status of each such request, and the length 

of time each such request has been pending, measured 

from the date of original request for an eligibility determination by the sponsor; 

‘‘(B) a review of the progress made in issuing GRASE 

determinations for requests not included in the reporting 

under subparagraph (A), including the number of such 

requests— 

21 USC 360fff–7. 


srobinson on DSKB307YQ1PROD with PUBLIC LAWS
PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2051 

LEGISLATIVE HISTORY—S. 2141 (H.R. 4250): 

HOUSE REPORTS: No. 113–558 (Comm. on Energy and Commerce) accompanying 

H.R. 4250. 

CONGRESSIONAL RECORD, Vol. 160 (2014): 

Sept. 17, considered and passed Senate. 

Nov. 13, considered and passed House. 

Æ 

‘‘(i) reviewed and the decision times for each 

request; 

‘‘(ii) resulting in a determination that the nonprescription sunscreen active ingredient, combination 

of nonprescription sunscreen active ingredients, or 

other ingredient is GRASE and is not misbranded; 

‘‘(iii) resulting in a determination that the nonprescription sunscreen active ingredient, combination 

of nonprescription sunscreen active ingredients, or 

other ingredient is not GRASE and is misbranded and 

the reasons for such determinations; and 

‘‘(iv) for which a determination has not been made, 

and an explanation for the delay, a description of the 

current status of each such request, and the length 

of time each such request has been pending, measured 

from the date of original request for an eligibility determination by the sponsor; 

‘‘(C) an annual accounting (including information from 

years prior to the date of enactment of the Sunscreen 

Innovation Act where such information is available) of the 

total number of requests submitted, pending, or completed 

under this subchapter, including whether such requests 

were the subject of an advisory committee convened by 

the Secretary; 

‘‘(D) a description of the staffing and resources relating 

to the costs associated with the review and decisionmaking 

pertaining to requests under this subchapter; 

‘‘(E) a review of the progress made in meeting the 

deadlines with respect to processing requests under this 

subchapter; and 

‘‘(F) to the extent the Secretary determines appropriate, recommendations for process improvements in the 

handling of requests under this subchapter, including the 

advisory committee review process. 

‘‘(b) METHOD.—The Secretary shall publish the reports under 

subsection (a) in the manner the Secretary determines to be the 

most effective for efficiently disseminating the report, including 

publication of the report on the Internet website of the Food and 

Drug Administration.’’. 

Approved November 26, 2014. 

Publication. 

Web posting. 


srobinson on DSKB307YQ1PROD with PUBLIC LAWS
PUBLIC LAW 113–195—NOV. 26, 2014 128 STAT. 2051 

LEGISLATIVE HISTORY—S. 2141 (H.R. 4250): 

HOUSE REPORTS: No. 113–558 (Comm. on Energy and Commerce) accompanying 

H.R. 4250. 

CONGRESSIONAL RECORD, Vol. 160 (2014): 

Sept. 17, considered and passed Senate. 

Nov. 13, considered and passed House. 

Æ 

‘‘(i) reviewed and the decision times for each 

request; 

‘‘(ii) resulting in a determination that the nonprescription sunscreen active ingredient, combination 

of nonprescription sunscreen active ingredients, or 

other ingredient is GRASE and is not misbranded; 

‘‘(iii) resulting in a determination that the nonprescription sunscreen active ingredient, combination 

of nonprescription sunscreen active ingredients, or 

other ingredient is not GRASE and is misbranded and 

the reasons for such determinations; and 

‘‘(iv) for which a determination has not been made, 

and an explanation for the delay, a description of the 

current status of each such request, and the length 

of time each such request has been pending, measured 

from the date of original request for an eligibility determination by the sponsor; 

‘‘(C) an annual accounting (including information from 

years prior to the date of enactment of the Sunscreen 

Innovation Act where such information is available) of the 

total number of requests submitted, pending, or completed 

under this subchapter, including whether such requests 

were the subject of an advisory committee convened by 

the Secretary; 

‘‘(D) a description of the staffing and resources relating 

to the costs associated with the review and decisionmaking 

pertaining to requests under this subchapter; 

‘‘(E) a review of the progress made in meeting the 

deadlines with respect to processing requests under this 

subchapter; and 

‘‘(F) to the extent the Secretary determines appropriate, recommendations for process improvements in the 

handling of requests under this subchapter, including the 

advisory committee review process. 

‘‘(b) METHOD.—The Secretary shall publish the reports under 

subsection (a) in the manner the Secretary determines to be the 

most effective for efficiently disseminating the report, including 

publication of the report on the Internet website of the Food and 

Drug Administration.’’. 

Approved November 26, 2014. 

Publication. 

Web posting. 


srobinson on DSKB307YQ1PROD with PUBLIC LAWS